1,4-Dioxane

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Overview

What Is It?

The compound 1,4-dioxane itself is not used as an intentionally added ingredient in cosmetic or personal care products. It is a manufacturing by-product that may be present in extremely low levels in some cosmetic and personal care product ingredients. These ingredients include certain cleansing materials (i.e., detergents), foaming agents, emulsifiers and solvents identifiable by the prefix, word, or syllables "PEG," "Polyethylene," "Polyethylene glycol," "Polyoxyethylene," "-eth-," or "-oxynol.

Can 1,4-dioxane be removed from ingredients used in cosmetic and personal care products?

While small residual amounts of 1,4-dioxane are unavoidable, manufacturers make significant efforts to reduce the concentration of residual 1,4-dioxane. Industry and FDA are aware of this issue and FDA has been monitoring the levels since the late 1970s. During this time manufacturers have made changes in their process that have resulted in a significant decline in the residual level. FDA has stated that the small, residual amounts of 1,4-dioxane that it has detected in cosmetics do not present a hazard to consumers.

Where else is 1,4-dioxane found?

1,4-dioxane is naturally found in trace amounts in cooked chicken, shrimp, and tomatoes. It can also be formed at low levels in certain food additives approved by the FDA for use in frozen desserts like ice cream and sherbets. The FDA has also set limits for 1,4-dioxane in glycerides and polyglycerides for use in products such as dietary supplements.

Scientific Facts:

Although frequently confused because of spelling, “1,4-dioxane” is not the same thing as the highly toxic environmental contaminant “dioxin” which is produced from burning fuels such as wood, coal, and oil. The two are different and unrelated substances. Dioxin is not found in any cosmetic or personal care products.

Safety

Safety Information:

The following safety information is excerpted from the U.S. Food and Drug Administration (FDA) website:

Is 1,4-dioxane in cosmetic products harmful?

The levels at which a chemical compound would be considered harmful in a cosmetic depend on the conditions of use (FD&C Act, section 601(a)). The 1,4-dioxane levels we have seen in our monitoring of cosmetics do not present a hazard to consumers.

Concerns initially were raised in the 1970s, when studies at the National Cancer Institute found an association between1,4-dioxane and cancer in animals when 1,4-dioxane was administered at high levels in the animal feed. However, the levels in cosmetic products are far lower [several thousand times lower] than those found to be harmful in feeding studies and, for the most part, the types of products in which it is found are only in contact with the skin for a short time [i.e., rinse-off products].

As a precaution, FDA followed up with skin absorption studies, which showed that 1,4-dioxane can penetrate animal and human skin when applied in certain preparations, such as lotions. However, further research by FDA determined that 1,4-dioxane evaporates readily, further diminishing the already small amount available for skin absorption, even in products that remain on the skin for hours.

What is FDA doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane?

FDA has been monitoring this issue since the late 1970s. It periodically monitors the levels of 1,4-dioxane in cosmetic products, and has observed that the changes made in the manufacturing process have resulted in a significant decline in the levels of this contaminant.

FDA has not established or recommended a specific limit on the level of 1,4-dioxane in cosmetics. The FDA has conducted surveys of raw materials and products for more than 30 years and has determined that it is not necessary to set limits for 1,4-dioxane. They have provided guidance to manufacturers alerting them to the health concerns and how to minimize 1,4-dioxane by means of a process called "vacuum stripping" at the end of the manufacturing process.

On the other hand, FDA’s review of some food contact substances has resulted in regulatory limits for 1,4-dioxane in food; FDA has also assessed the presence of 1,4-dioxane in certain drug products.

Phase 1: A target level of less than or equal to 25 ppm in finished products.

Phase 2: A target level of less than or equal to 10 ppm in finished products.

While the ICCR Traces WG acknowledges that different jurisdictions have taken different approaches for managing 1,4-dioxane in cosmetics, the group notes that the target levels above should include a suitable transition period to be set by each ICCR jurisdiction or applied by individual private companies. The ICCR Traces WG outlines the current approaches taken by ICCR jurisdictions to be as follows:

Canada: 1, 4-Dioxane was added to Health Canada’s Cosmetic Ingredient Hotlist in 2010. Therefore, 1, 4-dioxane should not be intentionally added to cosmetics legally sold in Canada, although residual levels are known to exist in many cosmetic/personal care and consumer products. As current levels of 1, 4-dioxane in products were considered not to pose undue risk to Canadians, no regulatory action (i.e. concentration levels) was deemed necessary. However, the Consumer Product Safety Directorate of Health Canada will continue to monitor dioxane levels in Canadian cosmetic and personal care products.

Europe: The Cosmetics Regulation (EC) No 1223/20093 states in recital (37) that "in order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe". In addition, article 17 (Traces of prohibited substances) states that "The nonintended presence of a small quantity of a prohibited substance, stemming 3 OJ L 342, 22.12.2009, p. 59. Traces/1,4-Dioxane Report/Final-January 2017 Page 6 from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.” Article 3 establishes that that any cosmetic product placed on the European Unions' market must be safe. In the Cosmetics Regulation, 1, 4-dioxane is listed in Annex II as a prohibited substance.

Japan: Japan has not set a level for trace admissible levels of 1, 4-dioxane in finished products or in raw materials. Japan approaches the control of levels of 1,4-dioxane in cosmetic products through raw materials.

United States: The FDA has not established or recommended a specific level for 1, 4-dioxane impurities in cosmetics. FDA has provided guidance to manufacturers alerting them to the health concerns and how to minimize 1, 4- dioxane by means of a process called "vacuum stripping" at the end of the polymerization process. This information is currently available in “1,4-Dioxane A Manufacturing Byproduct.”

More safety Information:

In 1988, 1,4-dioxane was added to the State of California's list of chemicals known to cause cancer under the Proposition 65 regulations. As part of the Proposition 65 regulations, however, California has established levels at which the chemicals listed under Proposition 65 for carcinogenicity and reproductive toxicity would not be considered a risk to consumers. These “Safe Harbor” levels are set through a rigorous scientific process in which the potential hazard of a substance is assessed and the information is used to set a safe level. The safe level set for 1,4-dioxane is 30 micrograms/day. The trace levels of 1,4-dioxane that may be present in some cosmetic or personal care products are well below these safe limits.